Roche drug approved as first-line blood cancer maintenance treatment

BASEL, Switzerland — Roche announced recently that the European Commission has approved the use of rituximab as a maintenance treatment for people suffering from follicular lymphoma, a common type of blood cancer, who have responded to initial induction therapy.

The approval of rituximab maintenance expands effective treatment options for people with this common type of incurable blood cancer, doubling the likelihood of them living longer without their disease worsening.

Maintenance treatment is an important approach to blood cancer management as it reduces the risk of relapse and the use of repeated chemotherapy, ultimately improving the lives of follicular lymphoma patients.

“The approval of rituximab maintenance therapy in the EU is a significant step that will change the way we manage this chronic disease,” said Professor Gilles Salles, of the Centre Hospitalier Lyon Sud, France, and principal investigator for the PRIMA trial.

“Having access to this new treatment option will enable patients with this serious form of blood cancer to live their lives with their disease under better control,” Salles said.

The approval is based on the results from the phase III PRIMA study which demonstrated that continuing rituximab for two years (maintenance treatment) in patients who responded to initial treatment with rituximab plus chemotherapy doubled the likelihood of these patients living without their disease worsening (known as progression-free survival) compared to those who did not receive maintenance therapy.

After two years of follow-up, 82 percent of patients who received rituximab maintenance were in remission compared to 66 percent of patients who did not.

The benefit of maintenance treatment was seen across all major patient groups analyzed within the trial, regardless of their tumor burden, age, gender or their response to initial treatment.

“The European approval of first line rituximab maintenance treatment of follicular lymphoma is excellent news for patients,” said Hal Barron, M.D., Head of Global Development and Chief Medical Officer at Roche. “Reducing the number of times the disease relapses and requires subsequent treatments will improve the lives of patients with this specific type of blood cancer.”